Document Control - Type-able Forms vs. Ink

keldez

Involved In Discussions
#1
Hello all,
I've run into a recent issue in joining a new company and having a different background/interpretation of what a controlled document is, specifically with forms.
Let's take a CAPA form for example. Our form is revision controlled and is locked down from any form of editing. This leaves no option but to complete the CAPA in ink.
With my background, forms like this and many others were revision controlled, but had flexibility so that the author could type in what was intended. Does this free you to completely adulterate the form? To a degree, but my take on it is with common sense, training, and final approval of the form being correct at completion, you've met the requirements.
I understand not every one will be a carbon copy, but I feel you lose the ability to complete your objective properly to what even the regulations say if your hands are so tied by being stuck with limited fields, using ink, etc.
I also feel with ink you can corner yourself into unintended damaging verbiage that cannot be corrected without possibly losing hours of work.
Options I've been presented with are attaching typed copies, which seems a step toward my point and somewhat ironic because the attachment is my vision of the form itself.

I've pushed for templates with as much Design Control documents as I could because it is a sort of new concept here and I have a lot of experience in knowing that inking out a Design Control project is by no means efficient. Please let me know your recommendations, and thanks!
 
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W

Wilderness Woody

#2
Re: Doc Control - Type-able forms vs. ink

Hello all,
Does this free you to completely adulterate the form? To a degree, but my take on it is with common sense, training, and final approval of the form being correct at completion, you've met the requirements.
To the extent that any person could FORGE a printed document with various adulteration, it's possible, but WHY would anyone bother?

Creating FORM TEMPLATES with easy access by appropriate staff to fill out in a prompt and complete manner just begs for functional forms. Interactive PDF's, Word, Excel or whatever framework you choose to use for convenience, reliability, access and control.

Have you seen and used the income tax filing forms for IRS? Do you think they are concerned about document control?! :tg:
 

outdoorsNW

Quite Involved in Discussions
#3
Re: Doc Control - Type-able forms vs. ink

I have seen PDF forms where the form is locked but text can be entered. I don't know the name of the product used to create these forms. I am guessing it is a product from adobe software

I have only used pdf forms a few times, and am not sure what the current form capabilites are.

Items to investigate on this option :
-Can the user save the files (not all pdf forms can)
-Is spell check available, and how well does it work?
-Is text formating such as bold, itallics, colors, bullets, etc. available?
-How does the form handle entries that are too long for the space allocated in the form?
-Can text be copied and pasted both into the form and out into another document? (Word, Powerpoint, email, etc)

Tom
 
Last edited:

keldez

Involved In Discussions
#5
Ok, those are some ideas we could try. Let's say your released form is 2 pages. Would you make your entry fields fixed in size so that the form doesn't push into 3,4,+ pages, thus not matching the released form?
Being a Quality Engr I play devil's advocate all of the time on things like this, so my opinion in this matter is you could have a 20 page result, as long as the original fields are properly titled per the released form, and nothing besides the number of pages has changed. Content, content, content.
What are your thoughts on this? :deadhorse:
 
W

Wilderness Woody

#6
Would you make your entry fields fixed in size so that the form doesn't push into 3,4,+ pages, thus not matching the released form?
The Template or Form SHOULD allow appropriate space to document the information required. Fixed sized fields should be used if and when appropriate to reinforce the need for a specific number or characters. It does not make sense to control the page length unless there is a functional reason to do so.
 
M

MikeSeymourAtl

#8
John Broomfield,

I've also come to Adobe XI as a viable source of forms. Note that the user's entries are saves as XML. This opens up a big potential. I've got a project in the works using that capability.

As an aside, I really like your tag line - "adding value faster while preventing loss sooner". That encapsulates what I see our profession to be all about. Can I use it? (I don't want to use it in the forum, just as a tagline to evangelize our mission.)
 

John Broomfield

Leader
Super Moderator
#9
John Broomfield,

I've also come to Adobe XI as a viable source of forms. Note that the user's entries are saves as XML. This opens up a big potential. I've got a project in the works using that capability.

As an aside, I really like your tag line - "adding value faster while preventing loss sooner". That encapsulates what I see our profession to be all about. Can I use it? (I don't want to use it in the forum, just as a tagline to evangelize our mission.)
Mike,

I've used this tag line since 1986.

Please PM me details of your mission.

Many thanks,

John
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#10
Hello all,
I've run into a recent issue in joining a new company and having a different background/interpretation of what a controlled document is, specifically with forms.
Let's take a CAPA form for example. Our form is revision controlled and is locked down from any form of editing. This leaves no option but to complete the CAPA in ink.
With my background, forms like this and many others were revision controlled, but had flexibility so that the author could type in what was intended. Does this free you to completely adulterate the form? To a degree, but my take on it is with common sense, training, and final approval of the form being correct at completion, you've met the requirements.
I understand not every one will be a carbon copy, but I feel you lose the ability to complete your objective properly to what even the regulations say if your hands are so tied by being stuck with limited fields, using ink, etc.
I also feel with ink you can corner yourself into unintended damaging verbiage that cannot be corrected without possibly losing hours of work.
Options I've been presented with are attaching typed copies, which seems a step toward my point and somewhat ironic because the attachment is my vision of the form itself.

I've pushed for templates with as much Design Control documents as I could because it is a sort of new concept here and I have a lot of experience in knowing that inking out a Design Control project is by no means efficient. Please let me know your recommendations, and thanks!
Many industries won't find revision control in forms to be critical. Most forms with type-entry fields are not alterable anyway. We just enter things in the fields; the form is functioning exactly as expected.

Some industries and their regulators do care about some types of forms, because of the records they will keep. Among them are food and drug (FDA) and equipment subject to Underwriters Laboratory (UL) oversight.

In general we frown on making changes to records once the information is taken down, unless we can see who made the change and when, and what the old data were. This is not easy on forms with fields unless there is an edit function. Again, what matters is the form's purpose and the expectations of who is overseeing your product, if any.

I hope this makes sense!
 
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